Food and Drug Law

Foodborne Illness Law: E. Coli, Salmonella, and More

February 3, 2020
Food and Drug Law, Product Liability, Public Health, Torts Law

Katherine Nixon, MJLST Staffer

Sometime in the fall of 2018, I walked into Chipotle hoping for a nice savory burrito bowl. The best burrito bowl—at least in my opinion—is made up of the following: brown rice, chicken, cheese, lettuce, hot salsa, sour cream, and guacamole. One ingredient missing can throw off the whole experience. Well, I walked into Chipotle only to find a printed sign on the glass in front of the various ingredients. Let’s be honest, that never means anything good. The sign notified customers that Chipotle would not currently be offering romaine lettuce due to an E. coli outbreak. At first, all I could think was “Noooo, not my beloved burrito bowl. What will it be like without the crunchy lettuce?”

In looking past my immediate concern over the negative effect that a lettuceless burrito bowl would have on my taste buds, I was ultimately thankful I had not eaten the romaine lettuce. Big picture things. It was discovered that the romaine lettuce came from a farm in Santa Barbara County, California. It was distributed through many avenues and not just to food establishments like Chipotle. Unfortunately, people became very sick. According to the Center for Disease Control and Prevention (CDC), 62 people were infected from 16 states and the District of Columbia. Further, 25 people were hospitalized and 2 people developed a form of kidney failure. This ended up being a big deal. That particular outbreak began in October 2018 and wasn’t declared over until January 9, 2019.

Believe it or not, E. coli outbreaks occur with some frequency. A massive outbreak that began in September 2019 was just declared over by the CDC on January 15, 2020. Again, the source of that outbreak was romaine lettuce. Other outbreaks in 2019 came from ground bison, flour, and ground beef. Aside from E. coli, there are other types of outbreaks as well. For instance, in 2019, there were several Salmonella outbreaks related to food items such as papayas and frozen raw tuna. Many people fell sick.

At this point, you might be wondering—what does this all have to do with law? It turns out there is a whole body of law generally referred to as “foodborne illness law.” I know—you definitely don’t learn about that in your normal law school curriculum. Yet, the name is somewhat self-explanatory. As succinctly put by the Public Health Law Center at Mitchell Hamline School of Law, “[A] person who is injured as a result of a foodborne illness may bring a civil cause of action against another by claiming that the other individual is legally liable for the harm caused by the foodborne illness.” Sometimes, there is even strict liability.

Overall, this type of law can be highly technical and usually involves the help of experts. It also can be quite difficult. Including the difficulty that often comes in discovering the source of a certain outbreak as well as the manufacturer of that source. It can be like piecing a giant puzzle together. However, once the pieces start to fit together, it all begins to make sense. If you have a science background, especially biology, this may be an area of law for you to consider. Next time you are at a family gathering and Uncle Eddy asks what you want to do, tell him you want to specialize in foodborne illness law. That will surely grab his attention.

Will the Vaping Industry Go Up in Smoke?

October 2, 2019
Administrative Law, Food and Drug Law, Health Law

Stephen Wood, MJLST Staffer

It’s no secret that vaping has become increasingly popular. The number of users has increased from 7 million in 2011 to 41 million as of 2018. The total market is now worth an estimated $19.3 billion. Less clear is the future of industry regulation in light of the recent respiratory illnesses linked to vaping. On September 24, 2019, the Centers for Disease Control and Prevention reported that vaping was attributed to 805 illnesses and 12 deaths. Pressure is building on the industry’s major players. In the last week, we have seen the cancellation of a merger between two of the largest tobacco companies, Altria and Philip Morris, and the release of the CEO of Juul, Kevin Burns.

However, the respiratory illnesses associated with vaping haven’t been linked to a specific product, and it is unclear what the long-term effects of vaping are. Because of this uncertainty, some states have implemented blanket restrictions on the sale of vaping products, President Trump has proposed new regulations, and the CDC has issued warnings regarding their safety. This is blindsiding the industry, which has been free from regulation by the FDA until recently.

Vaping devices, also known as electronic nicotine delivery systems (ENDS), became subject to the FDA’s regulatory scheme for all tobacco products on August 8, 2016. The Deeming Rule placed ENDS in the same category of products as cigarettes and other traditional tobacco products, which have been regulated under the Family Smoking Prevention and Tobacco Control Act since 2009. For this reason, the minimum age for purchasing ENDS is 18 years old, and the marketing, manufacturing, and distribution of ENDS is heavily regulated.

Juul, in particular, has come under fire for its marketing strategies. Among other claims, many lawsuits allege that the company specifically targeted minors through its use of social media and distribution of enticing flavors. These practices have also been the focal point of the recent surge of state regulations, which “are filling what many see as a regulatory void caused by federal inaction.” For example, in Michigan, Governor Gretchen Whitmer implemented an emergency ban, limiting the sale of vaping products to those which are tobacco flavored. New York did the same but exempted menthol from the ban. Massachusetts, notably, implemented a four-month emergency ban on all products. President Trump’s proposed ban, on the other hand, would be limited to flavored products.

If President Trump’s proposal is adopted, the industry would see an estimated 80% loss in sales. It will be interesting to see what the regulatory landscape looks like once the smoke clears.

Treating Depression With Ketamine? How the Investment Was Made

March 15, 2019
Administrative Law, Biotechnology, Food and Drug Law, Health Law

Hunter Moss, MJLST Staffer

Depression is a serious mental disorder that afflicts millions of Americans each year. One in three of these individuals struggles to find a treatment method that alleviates their condition, and are aptly said to suffer from treatment-resistant depression. In the most severe cases, treating depression can be a life or death decision—depression is the leading cause of over 41,000 suicides every year. For those dealing with depression, every day is a struggle to persevere and try to regain a sense of normalcy.

A new therapy for treatment-resistant depression was approved by the Food and Drug Administration (FDA) earlier this week, one that could help those that have been unable to find relief elsewhere. The unexpected source of the therapy is esketamine. If the name of this drug sounds familiar, it is because the name is based on, and molecularly similar to, the street drug named ketamine. While originally synthesized in the 1960’s as an anesthetic and first used widely in the Vietnam War, ketamine is now known as a party drug, providing the user with mild hallucinations and a sense of euphoria. Due to its dangerous side-effects and potential for abuse, ketamine was placed on the Schedule III of the United States Controlled Substance Act in August of 1999.

In the early 1990’s, researchers at Yale University first recognized the potential for ketamine to treat the symptoms of depression. Since then, scientists sought to confirm the viability of ketamine as a treatment option for individuals who did not experience relief from other treatment methods. A 2012 study out of Baylor College of Medicine proved just that: 85% of patients with severe depression reported the treatment to be effective. Unlike selective serotonin reuptake inhibitors (SSRIs), which are most commonly prescribed to treat depression and can take weeks to build in a patient’s system before becoming effective, ketamine can provide nearly immediate relief with its full effect being felt in as little as two days.

With the science firmly in place, the next hurdle advocates of ketamine faced was of perception—in the eyes of the FDA and the public alike. Radical clinics began to emerge across the country to provide patients suffering from treatment-resistant depression with a safe, heavily-monitored environment to undergo care. Because ketamine had yet to be recognized as a potential aid for depression by the FDA, clinic physicians would often have to prescribe the drug under the guise of using it as an anesthetic. The “don’t ask, don’t tell” approach to a new treatment for a severe mental disorder created some inevitable quandaries for both doctors and patients, who would be unable to receive insurance coverage for a non-FDA approved treatment program.

While the medical community was well aware of the healing potential of ketamine, pharmaceutical companies were reluctant to make the investment. The average price-tag of a clinical trial for the FDA is $19m. There is certainly a market for the drug with countless Americans suffering from depression. The issue holding pharmaceutical companies back is related to patent law. In order to receive a patent, the proposed invention must be novel—and considering that ketamine has been around for nearly sixty years, that would be an impossible claim to make. Without patent protection, the multi-million dollar investment is bad economics for big pharma, even if the trials could provide relief for millions of Americans.

So why did Janssen Pharmaceuticals, the developer of a treatment method for depression based on ketamine, make the investment and receive FDA approval for its new drug Sprovato? The answer is because Sprovato is esketamine, a sufficiently different molecule from ketamine to be patentable. Certain molecules can be left-handed and have right-handed doppelgangers. While it is beyond the scope of this blog piece (and the ability of its author) to explain the difference between the two, esketamine is the left-handed version of ketamine’s right hand. The deviation between the molecules is a significant enough difference to pass the novelty requirement necessitated by the U.S. Patent and Trademark Office (USPTO). While there is some debate as to whether esketamine is as effective as its counterpart, esketamine passed the FDA’s clinical trials and, for the most part, has been received as a viable alternative to ketamine treatment. This development could help legitimize the countless ketamine clinics that have emerged across the United States over the last few years, yielding a promising new alternative for those struggling with severe depression. At the same time, the story of ketamine raises questions about the roles of several actors in the health care system, specifically pharmaceutical companies, the FDA and the USPTO, in delaying the introduction of life saving medication in order to adhere their respective financial and regulatory requirements.

Supervised Injection Facilities: A Step in the Right Direction to Mitigate the Opioid Crisis or a Violation of Federal Law?

February 19, 2019
Biotechnology, Ethics, Food and Drug Law, Health Law

Jessica Swanson, MJLST Staffer

Plans for the nation’s first supervised injection facility hit a snag earlier this month when Philadelphia’s top prosecutor filed a federal complaint to keep it from opening its doors. Supervised injection facilities (SIFs) are legally sanctioned facilities that allow people to consume pre-obtained drugs under the supervision of trained staff and are designed to reduce the number of lives that would otherwise be lost to overdoses and provide a bridge to treatment. SIF staff members do not directly assist in consumption or handle any drugs brought in by clients, but are employed to provide sterile injection supplies, free testing, free distribution of the opioid overdose reversal medication, monitoring services for overdoses, and answers to questions about safe injection practices. SIF staff also offer general medical advice and referrals to drug treatment and other social support programs. There are approximately 120 SIFs currently operating in twelve countries around the world, but none in the U.S. However, a handful of U.S. cities, including New York, Seattle, Denver, San Francisco, and Delaware, have inched toward making SIFs a reality as each struggles to combat the increasing amount of drug-related deaths due to the opioid crisis. Philadelphia is by far the closest to becoming home to the nation’s first SIF, incorporated as “Safehouse.” However, on February 5th, the U.S. Attorney for the Eastern District of Pennsylvania, William McSwain, filed a lawsuit aimed at blocking Safehouse from opening its doors.

The civil lawsuit, which is jointly being pursued by Pennsylvania Attorney General Josh Shapiro and the Department of Justice in Washington asks a judge to declare such a facility illegal under federal law. Instead of waiting for Safehouse to open and then conducting arrests and a prosecution, McSwain is asking U.S. District Court Judge, Gerald McHugh, to rule on the legality of SIF plans in general. According to the complaint, a supervised injection site would violate a section of the 1986 Controlled Substances Act (CSA). The relevant section, also known as the “crack house statute,” was enacted during the height of the crack epidemic and was primarily used to shut down crack houses. The CSA makes it a felony punishable by up to 20 years in prison to knowingly open or maintain any place, regardless of compensation, for the purpose of using controlled substances. McSwain argues that Safehouse seeks to disregard the law and override Congress’ regulatory scheme by establishing, managing, and controlling sites in Philadelphia that will allow individuals to engage in the illicit use of controlled substances. Ronda Goldfein, vice president and attorney for Safehouse, argues CSA was not intended to apply to a medical facility focused on saving lives and moving people who are addicted to opioids into treatment. She argues the provision of the CSA in question is widely known to prosecute situations that involve crimes such as drug sales out of a car dealership or music festivals that allowed illegal drugs to flow freely. Safehouse, on the other hand, is a facility with good-faith efforts to improve public health.

Although other states like Pennsylvania are well-intentioned in opening SIFs, it is likely that the Controlled Substances Act is broad enough to encompass SIFs and thus bar them from operating. If Philadelphia or others want to open this type of site, they might want to steer their efforts towards changing the law. Overall, other cities that have expressed their intention of opening a SIF will be watching this case closely as it serves as an important test to determine the legality of SIFs.

Health Supplements: The “Wild West” of FDA Regulations

February 10, 2019
Administrative Law, Food and Drug Law

Gabe Branco, MJLST Staffer

At some point, we all have taken a multivitamin and/or some type of dietary supplement. They are hard to miss in most stores such as Target or Wal-Mart. The bright colored packaging and unfulfilling promises of “losing weight quickly” without dieting or “building muscle” without working out catches everybody’s attention. Most people assume that these products, ironically labeled “health” or “dietary” supplements, must be safe to ingest due to placing them in the same category as a “drug,” or because they deem the supplement to be “natural.” However, the reason people are mistaken is because the Food and Drug Administration (“FDA”) chooses to differentiate “health” products from “drugs.”

Under the FDA’s current regulatory scheme, “health” supplements are treated more like special foods than drugs. Drugs are considered unsafe until proven safe through clinical trials. These trials must be done on all drugs, even those that are sold without a required prescription. The trials must show that the drug is both safe and effective for the specified use. Once the drug is approved, manufacturers are subject to carefully monitored conditions and packaging requirements. The packaging requirement includes conditions the drug has been proven to treat, known side effects, contraindications, and unsafe interactions with other drugs. After the drug has been manufactured and released to the public for consumption, the FDA follows up on any adverse effects consumers and their doctors report, along with any adverse effects reported by the manufacturer.

“Dietary” supplements, on the other hand, are seen as safe until proven unsafe, a stark contrast to their drug counterpart. The Dietary Supplement Health and Education Act (DSHEA) defines “dietary” supplements as a category of food. As such, “dietary” supplements do not undergo the rigorous pre-manufacturing and post-manufacturing approval and monitoring process that drugs do. DSHEA prohibits supplements from containing anything that may have “a significant or unreasonable risk of illness or injury” when the supplement is used as directed on the label, or with regular use if there are no directions. While the regulation makes clear these supplements should not significantly or unreasonably expose the public to increased risk of harm, DSHEA fails to enforce the regulation with any preventative measures.

DSHEA effectively allows manufacturers to print any statement they wish on “dietary” supplement labels, so long as it is followed by the phrase “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” This practice is troublesome because the statement may suggest or claim outright that the “dietary” supplement treats symptoms or results in an outlandish outcome if taken. Even with the FDA warning, consumers would have little to no reason to assume that supplements placed on shelves everywhere could contain none of the listed ingredients or unknown ingredients that can cause adverse health effects.

The FDA has the authority to stop any production of “dietary” supplement if it is shown there is an increased risk of harm to the public. However, this only occurs after the release of the supplement and subsequent adverse effects impact consumers. Due to the lack of pre-manufacturing testing requirements, many “dietary” supplements contain germs, pesticides, or toxic heavy metals that may adversely impact consumers. In addition, many “dietary” supplements either do not contain what is listed on the label, contain more or less of what is listed on the label, or even contain ingredients not listed on the label. This issue could also stem from parties other than the manufacturers and sellers. Without any regulations pre-manufacturing, many suppliers of ingredients may mix or substitute the ingredients sold to manufacturers with less expensive or tainted filler ingredients.

These issues become problematic when an ingredient the FDA would deem a “drug” finds its way into a “dietary supplement.” Many male enhancers or muscle building “dietary” supplements have been found to contain substances much like Viagra or Cialis, which are regulated as “drugs.” In addition, certain weight loss supplements have been found to contain sibutraimine, which has been banned in the United States. All of these supplements were recalled by the FDA in a reactionary manner. However, in most instances a “dietary” supplement may contain a drug that has little to no known effects. Having little to no known effects makes it more difficult to detect if a “dietary” supplement indeed contains a drug, and if it then must undergo the more rigorous FDA drug requirements. By providing manufacturers and sellers a pathway to produce categorical “drugs” and distribute them to the public without undergoing the rigorous FDA drug testing processes, DSHEA potentially does more deregulation than regulation.

FDA regulations concerning “dietary” supplements should be as stringent as regulations governing drugs. The simplest solution would be to implement the same pre-manufacturing and post-manufacturing procedures that are required of “drug” manufacturers into the “dietary” supplement realm. Doing so would fulfill DSHEA’s requirement that the “dietary” supplements do not cause a significant or unreasonable increase in risk of injury or illness. Additionally, this would allow the FDA to regulate “drugs” to its fullest potential.

Animal-Product Substitutes – Does It Really Matter What We Call Them?

February 4, 2019
Agriculture, Animal Law, Climate Change, Food and Drug Law

Nick Hankins, MJLST Staffer

Fake meat is getting good, really good. The ImpossibleTM Burger 2.0, developed by Impossible Foods Inc., is a big upgrade from its 1.0 counterpart. The 1.0 has been referred to as a “good replacement for a bad burger” and compared to an “OK Sizzler steak” –not the type of reviews to make turncoats out of meateaters. The 2.0, on the other hand, was hailed as “a triumph of food engineering,” “a burger that could truly wean people off their meat lust,” and (probably most flatteringly) “a well-massaged Kobe ribeye.” Importantly, the latest Impossible Burger has real meat qualities, it can be juicy and red in the middle along with a texture containing small chunks like real beef.

Aside from being an obviously capable meat substitute, the Impossible Burger has the potential to get people to eat less beef and that’s good news because beef isn’t exactly environmentally friendly. In fact, beef is responsible for 41% of livestock greenhouse gas emissions, which account for 14.5% of total global emissions. The UN Intergovernmental Panel on Climate Change report found that changing our diets (including eating less meat) could contribute 20% of the effort necessary to keep global temperatures from risings 2°C above pre-industrial levels. So switching out regular burgers for ImpossibleTM ones might be one step in the right direction toward fighting global warming.

It turns out that not everyone is on board with meat substitution products, like the Impossible Burger. In February of last year, U.S. Cattlemen’s Association filed a petition with the U.S. Department of Agriculture calling for official definitions for the terms “beef” and “meat.” USCA argued, in its petition, that “[c]urrent labeling practices may cause consumer confusion in the market place.” However, it doesn’t look like this petition has gone very far. Unlike the U.S., France actually passed legislation that banned foods based largely on non-animal ingredients from being labeled as if they were. Recently, in response to lab grown meat (meat that is synthetically grown and not a vegetable substitution like the Impossible Burger) Terry Goodin, Indiana General Assembly representative, has put together a bill that aims to ensure that lab grown meat makers do not try to sell synthetic meat as the animal-grown original.

Manufacturers of meat alternatives argue that the ability to name their product after its meat analogue is important for branding their products to provide appropriate expectations to consumers. Names for animal product replacements like Soylent and “aquafaba” (a vegetable based egg replacement) simply don’t have the branding power to be super marketable. Considering that last year United States residents were projected to eat a record amount of meat, we might not want to bar meat alternatives from potential branding strategies just yet. In any case, it might not be worth a 20-year naming-rights battle, like the one currently being waged against dairy replacement products.

Impact of China’s Generics Push on Innovator Drug Companies

November 12, 2018
Administrative Law, Food and Drug Law, Intellectual Property

Sherrie Holdman, MJLST Staffer

With a population of 1.42 billion, China presents a large market for both innovator manufacturer and generic drug companies. Currently, about 95% of marketed drugs are sold by generics. However, many patients in China opt to use more expensive, imported, brand-name drugs. In an effort to address this problem, China’s State Council has announced its “Opinions Concerning Reforms of Policies to Improve the Supply and Utilization of Generics” to encourage the people of China to use generic drugs early this year. As a regulatory document, the Opinion shed light on the future direction of China’s generic market.

The Opinion identifies three important suggestions to guide implementation. The first suggestion is to promote research and development of generic drugs in China. The Opinion proposes a drug list to be compiled that identifies drugs for which generic counterparts don’t exist yet. The Opinion also encourages the government to develop key technologies in manufacturing generics. The second suggestion aims to improve the quality and efficacy of generic drugs. Generics will only be approved if their quality and efficacy are equivalent to the original drugs. To facilitate this goal, the State Council proposes speeding up the conformity assessment of quality and efficacy of generic drugs and improving the quality management of generic drugs. The third suggestion is to provide policy incentives for generics development, including implementation of a tax policy for generic manufacturers. Under this policy, a generic manufacturer, once designated as a “high technology enterprise,” will have a preferential tax rate of 15%, compared to the 25% rate for other companies. In order to be a “high technology enterprise,” the generic manufacturer will need to meet certain qualifications. Meanwhile, the Opinion encourages patentees to voluntarily grant compulsory licenses to Chinese generic manufacturers when there is “a serious threat to the public health.” However, despite its long existence in Chinese patent law and regulation, the compulsory licenses are historically rare in practice, partly because of the difficulty in defining what constitutes a “serious threat to the public health.”

In order to balance the interests of innovator and generic drug companies, the Opinion provides recommendations for strengthening the enforcement of intellectual property rights. For example, the Opinion proposes establishing an “early warning patent system” to prevent generic manufacturers from infringing on valid patents and thus mitigating the risk of infringement. Moreover, the State Council proposed to enhance accessibility of innovative drugs, especially imported oncology drugs, by applying no tariffs on imported new drugs. A five-year patent extension for new drugs was also proposed to enhance the intellectual property protection of innovator drugs.

Following the announcements promulgated in the Opinion, on April 25, 2018, China Food and Drug Administration (CFDA) released its “Public Comment Draft of Pharmaceutical Data Exclusivity Implementing Rules (provisional).” The Draft proposes that “innovative new drugs” will enjoy six years of data protection and “innovative therapeutic biologics” will enjoy 12 years of data protection. By proposing data protection for new drugs, China encourages multinational corporations to include China in international multicenter clinical trials and to concurrently apply for market introduction in China. Even if the new drug is introduced to China at a later time, the drug will still be entitled to a data protection period (e.g., from one to five years). The public comment period for the Draft was closed on May 31, 2018 and the final rule is expected soon.

Facing China’s generics push, innovator drug makers can strengthen their IP strategy in numerous ways. For example, companies should disclose information about the patents in the drug list in a timely manner, making the public and government aware of the patents. Further, companies should also establish a multi-directional scheme for IP rights protection including not only patent, but also knowhow, trade secret, design, trademark and copyright.

FDA’s Nutrition Innovation Strategy: The Right to Remain Silent on Added Sugars

November 5, 2018
Administrative Law, Food and Drug Law

Christina Petsoulis, MJLST Staffer

As of 2017, obesity rates in the United States reached 38.9%. It is without a doubt that poor diet is a major contributing factor to obesity prevalence. More specifically, diets consisting of convenience foods containing high amounts of added sugar serve as significant exposures leading to obesity and other comorbidities. A recent study reported that sugar was added to 66% of packaged foods.

While the sugar industry is quick to blame lack of physical activity for America’s obesity rates, research is clear that diets high in refined sugar increase the risk of obesity, cardiovascular disease, diabetes, fatty liver disease, cognitive decline and some cancers.

Though the linkages between food and obesity have been well established in scientific literature for some time, it is not until now that the Food and Drug Administration (FDA) has seriously recognized the importance of diet quality in chronic disease prevention.

On March 29, 2018, FDA commissioner, Dr. Scott Gotlieb, announced the Nutrition Innovation Strategy (NIS). Some of the key elements highlighted in the NIS include: modernizing claims, modernizing ingredient labels, modernizing standards of identity, implementing the nutrition facts label and menu labeling, and reducing sodium. The agency stated that it would be “committed to finding new ways to reduce the burden of chronic disease through improved nutrition.”

Gotlieb’s press release introducing the initiative seems to take a different perspective despite the agency’s intended goal.

In Gotlieb’s statement, he started by explaining the critical importance of a healthy diet in human health. He first introduced the importance of informed consumer choice as it relates to transparent labeling, then dove into the issue of “standards of identity.” Using milk as a key example, he explained that plant-based alternatives to cow’s milk, such as soy and almond-based beverages, labeled as “milk” create major public health concerns, including cases of kwashiorkor (protein deficiency disorder), and rickets (vitamin D deficiency disorder). He then went on to cite a case where a child was diagnosed with rickets as a result of parents assuming a soy-based beverage they fed their child contained the same nutritional qualities as cow’s milk. While the issue of standards of identity is relevant to public health nutrition in the context of protein deficiency and other forms of malnutrition, these issues have little relevance to obesity, or any other chronic disease for that matter.

It is surprising to see that Gotlieb’s press release does not highlight any of the important factors contributing to obesity in light of the initiative’s supposed goals. The worry, of course, is that the FDA is tip-toeing around food-industry players and, namely, the sugar industry in efforts to avoid conflict. The sugar industry is known for its aggressive efforts to shift blame for obesity on poor diet to lack of physical activity and poor consumer choice. For example, it was recently discovered that the sugar industry paid Harvard scientists to produce favorable results in their nutrition research on sugar’s role in heart disease.

While FDA has addressed the issue of sugar content through “added sugars” labeling requirements finalized in May 2016, little has been done to address sugar content in packaged foods. Serious efforts need to be taken to reduce sugar content in foods on the market to address the obesity epidemic

The Atlantic Mackerel Plight: Roadblocks to Prevent Overfishing

October 22, 2018
Agriculture, Animal Law, Food and Drug Law

Yvie Yao, MJLST Staffer

Atlantic mackerel, like sardines and herring, are small forage fish. Not only are they vital prey for seabirds and larger fish like bluefin tuna and cod, but also essential for the survival of ocean wildlife.

Although Atlantic mackerel are resilient to fishing pressure and bycatch risk, scientists announced this year that fishing activities along the coast have added too much pressure to the population of mackerel. That being said, Atlantic mackerel is overfished. On February 28, 2018, the federal government, unsurprisingly, declared that the catching cap for mackerel had been reached and the mackerel fishing season was officially closed for the rest of this year.

To prevent overfishing of a species, the Magnuson-Stevens Fishery Conservation and Management Act requires that local fish councils create a rebuilding plan as soon as possible, not to exceed 10 years. Conservative practices endorse setting a shorter rebuilding timeline with lower catch levels so that the species can recover as quickly as possible. Setting longer timelines with higher catch levels is risky. The species might be commercially inviable sooner than the projection and the council is less likely to reach its goal of rebuilding the under-stocked population. Moreover, low stock of the species is likely to negatively impact healthy and sustainable living of its predators in the ocean system.

The Magnuson-Stevens Act has been effective since it was first passed in 1976. Two amendments in 1996 and 2006 furthered the interest of fishery conservation, requiring local councils to place all overfished stocks on strict rebuilding timelines and mandate hard limits on total catches. These science-based provisions have recovered 44 fish stocks around the country and have generated $208 billion in sales in 2015 for fishermen.

However, this effective ocean fishery conservation law is facing challenges. On July 11, 2018, the House passed H.R. 200: Strengthening Fishing Communities and Increasing Flexibility in Fisheries Management Act. The bill, if it becomes law, would change rules about requirements to rebuild overfished stocks and allow councils to consider changes in an ecosystem and the economic needs of the fishing communities when establishing annual catch limits.

Recreational fishing and boating industry groups vehemently support this bill. They argue that the proposed changes would give alternatives to local councils to manage fish stocks, save taxpayers money, and modernize the management of recreational fishing.

Environmentalists and commercial fishermen oppose this bill. They argue that the proposed bill would let local councils rehabilitate them as fast as practicable, rather than rebuilding stocks as fast as possible, leading to looser regulation. The bill would also remove annual catch limits for short-lived species and ecosystem-component species, where forage fish including Atlantic Mackerel fall into the category. This backtrack from science-based policy would further delay restocking of forage fish and might even drive some species to commercial extinction.

It is unknown whether H.R. 200 will be passed in the Senate. Another companion bill S.1520, Modernizing Recreational Fisheries Management Act of 2017, envisions the same goal as H.R. 200. Will we be able to eat Atlantic Mackerel in the next ten years? The answer is uncertain. Regardless, the vote against such bill is a chance to “affirm that science, sustainability, and conservation guide the management of our ocean fisheries.”

“Juuling”: Gen Z’s Alleged Addiction May Mean Major Legal Problems for E-Cigarette Companies

October 6, 2018
Administrative Law, Agriculture, Business Law, Ethics, Food and Drug Law, Health Law, Product Liability, Public Health

By: Jack Kall, Minnesota Journal of Law, Science & Technology Vol. 20 Staffer

With every new week comes new headlines regarding Gen Z and their latest craze. After years of Millennials being cast as the generation responsible for everything wrong in the world, (Business Insider’s list of 19 things Millennials are killing, including everything from homeownership, banks, football, and oil to beer, napkins, cereal, and bars of soap; NPR describing how Millennials are killing Applebee’s; Forbes claiming Millennials might kill home-cooked meals and kitchens) it seems the media has found a new culprit, Gen Z! Gen Z’s supposed addiction to e-cigarettes, specifically to the JUUL brand, is common among the headlines.

Depending on how you define the generation, Gen Z includes anyone born in the years starting with 1995–2000 and ending between 2014–25. Pew Research has yet to name or define the end date of Gen Z, but it defines the “Post-Millennial generation” as those born 1997 and later.

No matter how you define Gen Z, it includes high school students, many of whom are under the legal tobacco consumption age of 18. High schoolers have been a major reason for both the rise of e-cig popularity and for giving JUUL Labs major market share in the e-cig industry. Browse through social media pages popular within the Gen Z community and you’ll inevitably see numerous posts about “Juuling.” However, Gen Z isn’t alone in its supposed obsession with e-cigs, as Leonardo DiCaprio (a member of Gen X) has long been known to appreciate vaping (e.g., 1, 2, 3).

JUUL Labs, which launched in 2015, has been repeatedly investigated for targeting minors through its advertising and sued for targeting teens with false claims of product safety. In 2017, Consumer Reports found that teens who vape are seven times more likely to turn to regular cigarettes. Additionally, the CDC has declared e-cig use among young people a public health concern.

As further research is published, JUUL should expect be the main target of continued legal action. One current case, a nationwide class action with ten named plaintiffs aged above 13, alleges in part that JUUL’s decision to market through social media was aimed at soliciting those under the legal smoking age. Another case, filed on behalf of a high school sophomore, alleges that JUUL is commonplace among his school, including use “on the school bus, in the bathrooms, outside of school and even in class.”

JUUL Labs will hope to continue to have success while under major legal scrutiny for its marketing practices. JUUL, importantly, hopes it can continue to show growth following its impressive financial valuation (most recently raising $1.2 billion in a financing round that valued the company at over $15 billion).

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